Urine Drug Cassette Test Performance Characteristics

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Drug Screen Cassette Performance Characteristics

Accuracy

A side-by-side comparison was conducted using the One Step Multi-Drug Test Cassette and commercially available drug rapid tests. Testing was performed on approximately 1,000 specimens previously collected from subjects presenting for Drug Screen Testing. Some specimens in the +/-25% cut-off levels were prepared by diluting from the more concentrated clinical specimens with the neat urine. Presumptive positive results were confirmed by GC/MS. Negative urine samples were screened initially by Predicate test. Approximately 10% negative samples were confirmed by GC/MS. The following compounds were quantified by GC/MS and contributed to the total amount of drugs found in presumptive positive urine samples tested.

Test	Compounds Contributed to the Totls of GC/MS
AMP	Amphetamine
BAR	Secobarbital, Butalbital, Phenobarbital, Pentobarbital
BZO	Oxazepam, Nordiazepam, -OH-Alprazepam, Desaky-frazepam
COC	Benzoylecgonine
THC	11-nor-9-carboxy-delta-9-tetrahydrocanabinol
MTD	Methadone
mAMP	Methamphetamine
MDMA	Methylenedioxymethamphetamine, Methylenedioxyamphetamine
MOP	Morphine, Codeine
OPI	Morphine, Codeine
OXY	Oxycodone
PCP	Phencyclidine
TCA	Amitriptyline, Desipramine, Doxepin, Imipramine, Nortriptyline, Desmethyldoxepin
COT	Cotinine, Nicotine
PPX	Propoxyphene, Norpropoxyphene

The following results are tabulated from these clinical studies:

Method		GC/MS
Multi-Drug Single-Line Test Card		Neg.	Neg. (<-25% cutoff)	Near cutoff neg. (-25% cutoff to cutoff)	Near cutoff pos. (cutoff to +25% cutoff)	Pos. (>25% cutoff)	% agreement with GC/MS
AMP	Positive	0	1	8	18	114	97%
AMP	Negative	149	1	5	4	0	95%
BAR	Positive	0	0	4	5	117	92%
BAR	Negative	150	2	6	1	10	99%
BZO	Positive	0	2	0	6	122	98%
BZO	Negative	150	9	2	2	1	98%
COC	Positive	0	2	15	16	103	98%
COC	Negative	150	5	7	1	1	91%
THC	Positive	0	13	9	12	109	89%
THC	Negative	150	6	0	0	1	99%
MTD	Positive	0	0	0	2	118	93%
MTD	Negative	150	17	10	8	1	>99%
mAMP	Positive	0	0	10	9	126	99%
mAMP	Negative	150	0	4	1	0	94%
MDMA	Positive	0	0	3	6	79	98%
MDMA	Negative	150	0	2	0	2	98%
MOP	Positive	0	1	4	4	115	98%
MOP	Negative	150	2	3	2	1	97%
OPI	Positive	0	0	16	18	116	>99%
OPI	Negative	150	0	0	0	0	90%
OXY	Positive	0		5	2	135	98%
OXY	Negative	147		8	2	1	97%
PCP	Positive	0	0	6	10	40	>99%
PCP	Negative	150	6	0	0	0	96%
*TCA	Positive	0	9	2	14	20	>99%
*TCA	Negative	150	24	7	0	0	94%
PPX	Positive	0	0	2	7	158	94%
PPX	Negative	152	5	18	10	0	99%
COT	Positive	0	0	0	50	74	>99%
COT	Negative	185	90	90	40	16	94%

Forty (40) clinical samples for each drug were run using each of The One Step Single Drug Test Strip by an untrained operator at a Professional Point of Care site. Based on GC/MS data, the operator obtained statistically similar Positive Agreement, Negative Agreement and Overall Agreement rates as trained laboratory personnel.

*Note: TCA was based on HP/LC data.

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